ISO 15189 Requirements for Quality and Competence
Understand the core requirements of ISO 15189 to enhance quality and competence in medical laboratories. This course introduces the standard’s structure, principles, and practical applications to support reliable results, regulatory compliance, and patient safety.
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ISO 15189 Requirements for Quality and Competence Overview
The ISO 15189 Requirements for Quality and Competence Course is designed to help laboratory professionals, quality managers, and compliance teams understand the structure and key clauses of ISO 15189. The course explains how the standard ensures the accuracy, reliability, and efficiency of medical laboratories by focusing on technical competence, risk-based thinking, and quality systems tailored to patient care.
Key Topics Covered
- ISO 15189 Fundamentals: Purpose, scope, and principles of quality and competence in medical laboratories
- Structural and Governance Criteria: Defining roles, responsibilities, and organisational requirements
- Process and Resource Management: Managing testing workflows, equipment, and staff competence
- Quality System Integration: Building a culture of improvement, risk management, and documented assurance
Course Benefits
- Strengthen quality outcomes: Improve laboratory performance through consistent practices and controls
- Understand accreditation criteria: Gain clarity on ISO 15189 clauses critical to regulatory and accreditation success
- Promote patient safety: Learn how to embed impartiality, confidentiality, and accuracy into daily operations
- Enhance professional capability: Develop skills that support internal quality systems, audits, and compliance
This course is suitable for individuals seeking to understand ISO 15189 in detail and apply it to their organisation's quality and competence objectives. It is ideal for:
- Laboratory Managers and Technicians
- Quality Managers and Coordinators
- Pathologists and Laboratory Directors
- Compliance and Accreditation Officers
- Medical Technologists
- Internal Auditors in Healthcare
ISO 15189 Requirements for Quality and Competence Outline
Module 1: Introduction to ISO 15189
Scope
Terms and Definitions
Module 2: General Requirements
Impartiality
Confidentiality
Requirements Regarding Patients
Module 3: Structural and Governance Requirements
Legal Entity
Laboratory Director
Laboratory Activities
Structure and Authority
Objectives and Policies
Risk Management
Module 4: Resource Requirements
General
Personnel
Facilities and Environmental Conditions
Equipment
Equipment Calibration and Metrological Traceability
Reagents and Consumables
Service Agreements
Externally Provided Products and Services
Module 5: Process Requirements
Pre-Examination Processes
Examination Processes
Post Examination Processes
Nonconforming Work
Control of Data and Information Management
Complaints
Continuity and Emergency Preparedness Planning
Module 6: Management System Requirements
General Requirements and Options
Management System Documentation
Control of Management System Documents
Control of Records
Action to Address Risks and Opportunities
Improvement
Corrective Action
Evaluations
Management Reviews
What You’ll Learn in this Course
By the end of the course, you will be able to:
Understand the structure and intent of ISO 15189
Interpret the general, structural, and resource requirements of the standard
Apply key process and management system clauses in a laboratory context
Identify areas of improvement in quality and patient-centred service delivery
Support your laboratory’s journey towards accreditation readiness
What’s Included
- ISO 15189 Examination
- Expert-led training by experienced healthcare auditors
- ISO 15189 Certificate of Completion
- Digital Delegate Pack
ISO 15189 Requirements for Quality and Competence Exam Details
To achieve the ISO 15189 Requirements for Quality and Competence Training, candidates will need to sit for an examination. The exam format is as follows:
Question Type: Multiple Choice
Total Questions: 30
Total Marks: 30 Marks
Pass Mark: 50%, or 15/30 Marks
Duration: 40 Minutes
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Completing the ISO 45001 Foundation Training provided me with a solid understanding of occupational health and safety standards. The training clarified legal requirements, hazard identification, and risk control measures. I’ve applied this knowledge to improve our incident response protocols and reinforce safety culture within the team. It’s also made me more effective at communicating compliance expectations and supporting ongoing H&S initiatives.
The ISO 22301 Foundation Training helped deepen my knowledge of business continuity planning and risk preparedness. The course content was practical and focused on real implementation challenges, which I could immediately relate to my role. I now play a more active part in reviewing continuity plans and coordinating recovery strategies. The training has improved how we manage operational risks and strengthened our overall resilience.
I registered my team in the ISO 9001 Lead Implementer Training, and the improvements were visible right away. The training gave us the tools to standardise workflows, enhance documentation, and build a consistent quality management system. The team has taken ownership of processes and is now more proactive in identifying areas for improvement. It’s significantly enhanced how we align with best practices and deliver results with greater reliability.
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Frequently Asked Questions
What is the ISO 15189 Requirements for Quality and Competence Course about?
This course provides an introduction to ISO 15189 and helps learners understand the quality and competence requirements for medical laboratories.
Do I need any laboratory experience to take this course?
No prior experience is necessary, although it is helpful. The course is designed for beginners as well as professionals working in quality or laboratory functions.
Is ISO 15189 relevant only to hospitals?
No, ISO 15189 applies to any medical or clinical laboratory, including private diagnostic centres, public health labs, and university research facilities.
What version of the ISO 15189 standard does this course cover?
The course covers the most recent version of ISO 15189 and includes updates on quality, governance, and technical competence.
Does this course prepare me for ISO 15189 accreditation?
Yes, the course gives foundational knowledge needed to begin preparing your lab for ISO 15189 implementation and future assessments.
